Evaluation of the Efficacy of Cesamet™ for the Treatment... | NCT00380913

Studies
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy

NCT00380913

Sponsor

NEMA Research, Inc.

Status

Completed

Last Update Posted

Feb 15, 2008Estimated

Enrollment

23Estimated

Phase

Phase 4

Conditions

Diabetic Neuropathies

Interventions

Cesamet™ (nabilone)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Sep 25, 2006

First Submission Date that Met QC Criteria

Sep 25, 2006

First Posted Date

Sep 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2008

Last Update Posted Date

Feb 15, 2008Estimated

Description Module

Brief Summary

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.

Detailed Description

The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to diabetic peripheral neuropathy.

This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due diabetic peripheral neuropathy. The study has two phases: a Pretreatment Phase and a Treatment Phase.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Estimated

Name	Type	Description	Arm Group Labels	Other Names
Cesamet™ (nabilone)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Average Pain Score at target site.

Secondary Outcomes

Measure	Description	Time Frame
The Worst Pain Score at target site.
The Pain at Night Score at target site.
Quality of Life measures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with diabetic peripheral neuropathic pain
Chronic daily pain present for at least 2 months
On stable analgesic regimen for one month
Baseline pain score greater than 40mm on a visual analog scale

Exclusion Criteria:

Hypersensitivity to compounds in study drug or similar drugs
Pregnant or lactating females
Drug or alcohol abuse
Unstable medical condition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph V Pergolizzi, MD	NEMA Research, Inc.	Principal Investigator
Charlotte Richmond, PhD	Nema Research	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Florida Medical Research		Aventura	Florida	33180	United States
Sunrise Clinical Research, Inc.

Label	URL
Nema Research website	View source

Condition Browse Module

MeSH Terms

ID	Term
D003929	Diabetic Neuropathies

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C011941	nabilone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided